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Veltassa (patiromer sorbitex calcium) – Labelling - V03AE09

Updated on site: 10-Oct-2017

Medication nameVeltassa
ATC CodeV03AE09
Substancepatiromer sorbitex calcium
ManufacturerVifor Fresenius Medical Care Renal Pharma France

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – Veltassa 8.4 g

1.NAME OF THE MEDICINAL PRODUCT

Veltassa 8.4 g powder for oral suspension patiromer

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

powder for oral suspension 30 sachets

60 sachets

90 sachets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Take within 1 hour after preparation of suspension.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Can be stored below 25°C for up to 6 months.

Date when taken out of the refrigerator:______

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vifor Fresenius Medical Care Renal Pharma France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

12.MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/17/1179/001

30 sachets

EU/1/17/1179/002

 

60 sachets

 

EU/1/17/1179/003

 

90 sachets

 

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

VELTASSA 8.4 G

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

SACHET of Veltassa 8.4 g

1. NAME OF THE MEDICINAL PRODUCT

Veltassa 8.4 g powder for oral suspension patiromer

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

powder for oral suspension

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Take within 1 hour after preparation of suspension.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Can be stored below 25°C for up to 6 months.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vifor Fresenius Medical Care Renal Pharma France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – Veltassa 16.8 g

1. NAME OF THE MEDICINAL PRODUCT

Veltassa 16.8 g powder for oral suspension patiromer

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

powder for oral suspension 30 sachets

60 sachets

90 sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Take within 1 hour after preparation of suspension.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Can be stored below 25°C for up to 6 months.

Date when taken out of the refrigerator:______

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vifor Fresenius Medical Care Renal Pharma France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

12. MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/17/1179/004

30 sachets

EU/1/17/1179/005

 

60 sachets

 

EU/1/17/1179/006

 

90 sachets

 

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VELTASSA 16.8 G

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

SACHET of Veltassa 16.8 g

1. NAME OF THE MEDICINAL PRODUCT

Veltassa 16.8 g powder for oral suspension patiromer

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

powder for oral suspension

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Take within 1 hour after preparation of suspension.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Can be stored below 25°C for up to 6 months.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vifor Fresenius Medical Care Renal Pharma France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – Veltassa 25.2 g

1. NAME OF THE MEDICINAL PRODUCT

Veltassa 25.2 g powder for oral suspension patiromer

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

powder for oral suspension 30 sachets

60 sachets

90 sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Take within 1 hour after preparation of suspension.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Can be stored below 25°C for up to 6 months.

Date when taken out of the refrigerator:______

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vifor Fresenius Medical Care Renal Pharma France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

12. MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

EU/1/17/1179/007

30 sachets

EU/1/17/1179/008

 

60 sachets

 

EU/1/17/1179/009

 

90 sachets

 

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VELTASSA 25.2 G

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

SACHET of Veltassa 25.2 g

1. NAME OF THE MEDICINAL PRODUCT

Veltassa 25.2 g powder for oral suspension patiromer

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

powder for oral suspension

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Take within 1 hour after preparation of suspension.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Can be stored below 25°C for up to 6 months.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vifor Fresenius Medical Care Renal Pharma France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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